This study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe for sexually-active young adults in Botswana without HIV infection and whether it will reduce their risk of getting an HIV infection.

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

Adverse drug reactions in the tenofovir and placebo arms

HIV incidence in the tenofovir and placebo arms

Secondary Outcome Measures:

Changes in levels of unprotected sex during the trial

Adherence to medication

Antiretroviral (ARV) resistance patterns in seroconverters

Viral set point in seroconverters

Estimated Enrollment:

1200

Study Start Date:

September 2005

Study Completion Date:

March 2007

Detailed Description:

Twelve hundred healthy, sexually active women and men, 18-29 years old, without HIV infection will be enrolled in Francistown and Gaborone, Botswana. They will be provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. In addition, volunteers will be randomized to receive either Tenofovir or a placebo pill to take once a day. Volunteers will be seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status. Persons who become HIV infected during the trial will receive ongoing supportive counseling, CD4 and viral load monitoring, education about HIV infection/disease, and access to HIV care including free antiretrovirals when clinically indicated. Volunteer safety will be monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board.

Eligibility

Ages Eligible for Study:

18 Years to 29 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

citizen of Botswana 18-29 years old

sexually active

HIV uninfected

Hepatitis B and C uninfected

Calculated creatinine clearance >= 60 mL/min

hemoglobin >= 8 gm/dL

ALT and AST <= 2x ULN

total bilirubin <= 1.5 mg/dL

total serum amylase <= 1.5x ULN

Serum phosphorus >= 2.2 mg/dL

willing to use effective contraception

living within 1 hours travel of study clinic

pass comprehension test

willing and able to give informed consent

Exclusion Criteria:

history of significant renal or bone disease

any chronic illness requiring ongoing prescription medication

pregnant or breastfeeding

planning to move away from site in the next year

participating in another HIV prevention or vaccine safety trial

any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111150